Health care assessment includes the review and analysis of physiometry collected and recorded by electronic data sensors. The type and quality of physiometry can depend upon the type and location of sensor used. External sensors, such as thermometers, blood pressure cuffs, heart rate monitors, and the like, are limited in the kinds of information, which they are able to collect, and can encumber the patient. Implantable in situ sensors can provide a direct stream of recorded physiometry, but are invasive and require surgical implantation.
Recent advances in microchip technology have created a new generation of highly integrated, implantable monitors, sensors and medical devices, such as implantable cardioverter defibrillators, pacemakers, and insertable loop recorders. For instance, PCT Publication Nos. WO/2000/004945, to Habib et al., published Feb. 3, 2000, and WO/2000/004946, to Habib et al., published Feb. 3, 2000, respectively describe an implantable sensor chip and treatment regiment, the disclosures of which are incorporated by reference. Each sensor chip can collect and transmit physiometric data by wireless telemetry to a receiver external to a body. Similarly, the emerging Bluetooth wireless communication standard, described at http://www.bluetooth.com/developer/specification/specification.asp, proposes a low cost, small form factor solution for short range data communications, potentially suitable for use in implantable sensor technology.
Nevertheless, microchip sensors must still be implanted via some form of surgical procedure with the need to provide a sterile field, surgical staff, and surgical risks. Minimally invasive implantation using large bore needles or flat-edged blades is impracticable because sensors, particularly when embodied using microchip technology, favor a prismatic shape with substantially rectangular cross sections that are incompatible with circular bores.
As well, large bore needles can core out flesh, skin, or hide, when used in animals, as the instruments are inserted subcutaneously, which creates a risk of injury, scarring, and infection. Additionally, cored flesh trapped within the needle's bore can clog or interfere with correct implant placement. Moreover, wider-tipped instruments, such as a hollow point chisel, can potentially cause tearing, gouging, or similar injury due to the width of the cutting edge.
Also, achieving a desired subcutaneous depth for implant placement can be difficult using a large bore needle. Typically, a plunger pushes an implant through the needle and into the recipient's tissue. The tip of the large bore needle creates an opening conformably surrounding the needle inserted in the tissue. Prior to placing the implant, the needle must be withdrawn to create space, which can be risky and tedious. A physician must carefully withdrawal the needle to create a sufficient space for the implant while ensuring that the needle is not completely withdrawn. Otherwise, another incision must be made.
Further, an incising tool can extend the opening to create space for the implant to prevent withdrawal of the needle. Once the large bore needle is inserted into the recipient, the incising tool is introduced and an extension of the opening is cleared. Subsequently, the incising tool is removed and a plunger is introduced. The plunger pushes the implant into the extended opening without moving or repositioning the needle. Separate uses of the incising tool and plunger can contaminate the environment by exposing the implant to the external environment and can create a risk of infection. Additionally, the separate tools can be difficult to maneuver and may require assistance from a further physician or technician.
In addition, although current surgical implantation approaches attempt to minimize the size of incision and degree of invasiveness, implantation is, at best, costly, time-consuming, traumatic, requires multiple instruments and maneuvers, and potentially risky to the patient. For example, anesthetizing is conventionally performed using a topical or local anesthetic agent on the implantation site.
Subcutaneous implantable sensors offer the best compromise between in situ sensors and external sensors and are potentially insertable with a simple injection, rather than surgical procedure. These sensors are typically implanted below the dermis in the layer of subcutaneous fat. Several approaches to the subcutaneous implantation of solid materials have been described.
An insertion and tunneling tool for a subcutaneous wire patch electrode is described in U.S. Pat. No. 5,300,106, to Dahl et al., issued Apr. 5, 1994. The tunneling tool includes a stylet and a peel-away sheath. The tunneling tool is inserted into an incision and the stylet is withdrawn once the tunneling tool reaches a desired position. An electrode segment is inserted into the subcutaneous tunnel and the peel-away sheath is removed. Although providing a tool for subcutaneous implantation, the Dahl device requires an incision into the subcutaneous fat layer and forms an implantation site larger than the minimum sized required by the electrode segment. Further more, the cylindrical bore precludes the injection of non-conforming solid sensors or materials. As well, external exposure to the inside of the peel-away sheath with risk of injury are possible when the stylet is removed.
An implant system for animal identification that includes a device for implanting an identification pellet in a fat layer beneath the hide or skin of an animal is described in U.S. Pat. No. 4,909,250, to Smith, issued Mar. 20, 1990. The device includes a curved needle-like tube that terminates at a tapered, sharpened point. An elongated, flexible plunger is slidably received within the needle-like tube. The pointed tip is inserted through the hide or skin and the plunger is actuated to drive the identification pellet from the tip into the fat layer. However, the Smith device uses an oversized open bore, which can cause coring of the hide or flesh and the device must be partially withdrawn to implant the identification pellet.
A trocar for inserting implants is described in PCT Publication No. WO/1999/053991, to Peery, published Oct. 28, 1999. An implant retention trocar includes a cannula for puncturing the skin of an animal and an obturator for delivering the implant. A spring element received within the cannula prevents an implant from falling out during the implant process. The cannula has a distal tip design, which causes a minimum of trauma and tearing of tissue during implant insertion. However, the distal tip design is specifically directed to cannulas having a substantially circular bore and thereby limits the size and shape of implant, which can be inserted through the Clarke trocar. Further, the implant is delivered into the tissue via the obturator directly adjacent to the cannula, rather than a further distance from the cannula. Deeper implantation of the implant requires use of a separate clearing tool, which risks misalignment of the cannula.
An instrument for injecting implants through animal hide is described in U.S. Pat. No. 5,304,119, to Balaban et al., issued Apr. 19, 1994. The instrument includes an injector having a tubular body divided into two adjacent segments with a hollow interior bore. A pair of laterally adjacent tines extends longitudinally from the first segment to the distal end of the tubular body. A plunger rod has an exterior diameter just slightly larger than the interior diameter of the tubular body. With the second segment inserted beneath the animal hide, the push rod is advanced longitudinally through the tubular body, thereby pushing the implant through the bore. As the implant and rod pass through the second segment, the tines are forced radially away from each other, thereby dilating or expanding the incision, and facilitating implant. The instrument is removed from the incision following implantation. Though avoiding the coring of animal hide or flesh, the instrument forms an implantation site larger than the minimum sized required by the implant and causes potentially damaging compaction of the implant against the laterally adjacent times during implant delivery. Additionally, the implant is merely advanced into the animal hide or flesh without first clearing a pathway in the animal hide or flesh. Use of a trocar or other clearing device to clear a pathway would require removal of the plunger rod and insertion of the trocar in the tubular body.
Therefore, there is need for a non-surgical instrument and method for subcutaneous implantation of sensors and solid materials that preferably does not require an incision preparatory to instrument insertion.
There is a further need for a subcutaneous implantation instrument and method capable of implanting sensors and other solid materials that are not readily disposed to implantation through a substantially circular bore. Moreover, there is a further need for a subcutaneous implantation instrument and method which is minimally invasive, preferably creating the smallest needed implantation site, and capable of implantation without exposing the implant to longitudinal stresses.
There is a still further need for an implantation instrument that provides a progressive widening of an implantation site. Such progressive widening would facilitate the use of wider-tipped instruments that provide sufficient girth to admit implantable sensors and medical devices with lowered patient trauma. Preferably, such an instrument would include provision for application of an anesthetic agent.
There is yet a further need for an implantation instrument with a multi-part plunger that allows precise subcutaneous dissection of an implant site without requiring risky repositioning of a needle tip or introduction of a separate clearing tool in situ.